FDA 510(k) Application Details - K132027

Device Classification Name	More FDA Info for this Device
510(K) Number	K132027
Device Name	OEC 9800 PLUS
Applicant	GE OEC MEDICAL SYSTEMS, INC 384 WRIGHT BROTHERS DR. Salt Lake Cty, UT 84116 US Other 510(k) Applications for this Company
Contact	JEFF WAGNER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2013
Decision Date	05/01/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review